Patent No. US11064937 (titled "Method And Device For In-Home Sleep And Signal Analysis") was filed by Cleveland Medical Devices Inc on Jan 11, 2021.
’937 is related to the field of sleep analysis and, more specifically, to systems and methods for conducting sleep studies in a patient's home rather than in a sleep laboratory. The background highlights the prevalence of sleep disorders and the limitations of traditional polysomnography (PSG), which requires patients to sleep in a lab setting. This can be inconvenient, expensive, and may not accurately reflect a patient's typical sleep patterns due to the "first night effect".
The underlying idea behind ’937 is to create a portable, wireless system that allows for remote, attended sleep analysis in the patient's home. This involves collecting physiological and kinetic data using various sensors, transmitting this data wirelessly to a remote monitoring station, and allowing a remote monitor to observe the patient and communicate with them if necessary. The system aims to replicate the benefits of a lab-based PSG while overcoming its limitations.
The claims of ’937 focus on a system comprising a portable patient interface box connected to sensors that measure airflow (via a nasal cannula or facemask), respiratory effort (via a respiratory effort belt), and blood oxygenation (via a fingertip pulse oximeter). The interface box includes a processor, non-volatile memory, pressure transducers, and a transceiver for wireless data transfer to a remote database. Software analyzes the data to identify physiological and technological events indicative of a sleeping disorder.
In practice, the patient wears the sensors and the portable interface box while sleeping at home. The interface box digitizes the sensor data and transmits it wirelessly to a remote database. The software then analyzes this data, looking for patterns and events that suggest a sleep disorder. The system also incorporates a kinetic sensor to measure body position, which can be used to correct for motion artifacts in the data. A key aspect is the ability to remotely monitor the patient and communicate with them, allowing for adjustments to sensor placement or other interventions during the study.
The system differentiates itself from prior approaches by enabling real-time, attended home sleep studies . Unlike previous home PSG systems that stored data for later retrieval, ’937 transmits data wirelessly, allowing for continuous monitoring and intervention. The use of software to identify physiological and technological events, combined with the ability to communicate with the patient, creates a remotely attended sleep study that can provide more accurate and reliable results than unattended home tests, while being more convenient and cost-effective than traditional lab-based PSGs.
In the mid-2000s when '937 was filed, systems commonly relied on wired or wireless transmission of sensor data to a central processing unit. At a time when sleep studies were typically conducted in specialized labs, hardware or software constraints made remote, unattended sleep monitoring non-trivial. When systems commonly relied on specialized hardware for signal processing, software-based filtering and artifact correction were emerging techniques.
The examiner approved the application because the prior art, whether considered individually or in combination, did not teach all the elements of the claimed system for remote sleep analysis. Specifically, prior art failed to disclose a system including a nasal cannula/facemask, respiratory belt, fingertip pulse oximeter, and a portable patient interface box with specific components like air ports and pressure transducers. Furthermore, the prior art did not teach software adapted to identify physiological or technological events indicative of a sleep disorder, nor releasable sensor inputs connecting the respiratory effort belt and fingertip pulse oximeter.
This patent contains 20 claims, with independent claims numbered 1 and 13. The independent claims are directed to systems for conducting remote or at-home sleep analysis using sensors, a portable interface box, a remote database, and software for identifying sleep disorders. The dependent claims generally elaborate on specific features, components, or functionalities of the systems described in the independent claims.
Definitions of key terms used in the patent claims.
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